Double Blind Atorvastatin Amlodipine Study - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159718

Purpose

To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia.

Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.

Condition	Intervention	Phase
Angina	Drug: amlodipine Drug: atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).

Secondary Outcome Measures:

Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and
week 26. Inflammatory markers to be analyzed are the following: C-reactive
protein, amyloid A and interleukin 6.
From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
onset of angina and total exercise time will be assessed at baseline (week 2),
week 18 and week 26.

Estimated Enrollment:	360
Study Start Date:	July 2001
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.
Total cholesterol > 5.2 mmol/L (200 mg/dL) on diet alone.

Exclusion Criteria:

Myocardial infarction within 2 months prior to the study.
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159718

Show 33 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deanfield JE, Sellier P, Thaulow E, Bultas J, Yunis C, Shi H, Buch J, Beckerman B. Potent anti-ischaemic effects of statins in chronic stable angina: incremental benefit beyond lipid lowering? Eur Heart J. 2010 Nov;31(21):2650-9. Epub 2010 May 21.

ClinicalTrials.gov Identifier:	NCT00159718 History of Changes
Other Study ID Numbers:	A0531031
Study First Received:	September 8, 2005
Last Updated:	January 29, 2008
Health Authority:	Poland: Ministry of Health

Additional relevant MeSH terms:

Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Amlodipine
Atorvastatin
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012